Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

Hazard

Osstem Implant Co. Ltd, is voluntarily initiating a medical device correction involving the current labeling for this electronic product may be missing a required Certification Statement under 21 CFR Subchapter J (Radiological Health Regulations). Specifically, the following statement may have been omitted: Certification Statement: This electronic product complies with all applicable performance standards prescribed under 21 CFR Subchapter J, as enforced by the U.S. Food and Drug Administration at the date of manufacturing.

Affected products

• Osstem Dental X-Ray System T2Plus. Product Model Numbers T2-C-P and T2-CS-P.

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